Sticky Jackfruit Burgers

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All the taste and experience of pulled pork, without the increased risk of cancer and metabolic disease. On the contrary, jackfruit introduces lots of fiber, vitamins, carotenoids, and flavanones. We’ll have to do a main feature about jackfruit sometime; it’s an unusual fruit especially for its protein content, but for now, let’s get cooking!

You will need

  • 1 can (14oz/400g) green jackfruit, drained (the flesh will not, in fact, be green—this is referring to the fruit being unripe and thus still firm in texture, which is what we want. The outside of the fruit, which will not be in the can, will have been green)
  • 1/4 red cabbage, thinly sliced
  • 1/2 carrot, grated
  • 6 mangetout, thinly sliced
  • 2 tbsp mayonnaise (your preference what kind, and yes, vegan is fine too)
  • 1 tbsp extra virgin olive oil
  • 1 tbsp gochujang paste (if you can’t find gochujang paste locally, you can either order it online (here it is on Amazon) or substitute with harissa paste, which is not the same—it uses different spices—but will do the same job here re texture, umami taste, and level of spiciness)
  • 1 tbsp soy sauce
  • 1 tbsp balsamic vinegar
  • 1 tsp apple cider vinegar
  • 1 tsp garlic paste
  • 1 tsp tomato paste
  • 1 tsp ginger paste
  • 1 tsp chili flakes
  • 3½ fl oz water
  • 2 burger buns (unless you make them yourself, burger buns will probably not be healthy; you can, however, also look for small round wholemeal breads—the name of which varies far too much by region for us to try to get a catch-all name here—and use them in place of burger buns)

Method

(we suggest you read everything at least once before doing anything)

1) Combine the garlic paste, ginger paste, tomato paste, gochujang paste, soy sauce, balsamic vinegar, and chili flakes in a saucepan

2) Boil the 3½ fl oz water we mentioned; add it to the saucepan, mixing well, turn on the heat and let it simmer for 5 minutes or until it is thick and sticky (it will thicken more as it cools, too, so don’t worry if it doesn’t seem thick enough yet). Set it aside.

3) Dry the jackfruit (using strong kitchen paper should be fine), add the olive oil to a skillet and bring it to a high heat; add the jackfruit and fry on both sides for a few minutes, until it looks cooked (remember, while this may look like animal meat, it’s not, so there’s no danger of undercooking here).

4) When the jackfruit looks a nice golden-brown, add two thirds of the sauce from the saucepan, and break apart the jackfruit a bit (this can be done with a wooden/bamboo spatula, so as to not damage your pan), When it all looks how you’d expect pulled jackfruit (or pulled pork) to look, take it off the heat.

5) Combine the carrot, cabbage, and mangetout in a small bowl, adding the apple cider vinegar and mixing well; this will be the coleslaw element

6) Mix the remaining sauce with the mayonnaise

7) (optional) toast the burger buns

8) Assemble the burgers; we recommend the following order: bottom bun, pulled jackfruit, coleslaw, gochujang mayo, top bun

Enjoy!

Want to learn more?

For those interested in some of the science of what we have going on today:

Take care!

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  • Ozempic Helps People Walk Further

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    There’s often a catch-22 when it comes to exercise: it’s important for good health, and/but people with ill health usually cannot exercise much.

    A recent (published today, at time of writing, the 29th of March 2025, never let it be said we don’t bring you the very most up-to-date health science!) study by Dr. Neda Rasouli et al. has shown there is a possible way through that catch-22, depending on the nature of the illness.

    This study followed 792 people across 112 outpatient clinical trial sites in 20 countries in North America, Asia, and Europe, with type 2 diabetes and peripheral artery disease.

    What they found

    Patients taking semaglutide (specifically, 1mg Ozempic) enjoyed a 21% median increase in walking distance, as well as some bonus benefits, namely:

    • Weight reduction: the semaglutide group saw a greater reduction in body weight (–4.1 kg; P < 0 .0001)
    • HbA1c levels: semaglutide lowered HbA1c by 1 percentage point (P < 0.0001)
    • Blood pressure: systolic blood pressure decreased by 3.2 mmHg (P = 0.0042)

    You may be wondering what that “P =” means: it’s the probability of this occurring by random chance, on a scale from zero (impossible outcome) to 1 (unavoidable outcome).

    For example:

    “We hypothesized that singing the happy birthday song before tossing a coin would result in it landing on heads. We sang the happy birthday song and tossed the coin; it landed on heads (P = 0.5)”

    In science, generally speaking anything with a probability of under 0.05 (expressed as: “P < 0.05”) is considered a statistically significant result.

    All this to say, the cited figures of, for example, P < 0.0001, are very significant indeed.

    On which note, that 21% median increase in walking distance? P < 0.0004.

    As for side effects? Serious adverse events related to the drug occurred in 1% of the semaglutide group vs 2% in the placebo group. So, that seems quite safe indeed.

    You can find the paper itself here:

    Semaglutide and walking capacity in people with symptomatic peripheral artery disease and type 2 diabetes (STRIDE): a phase 3b, double-blind, randomised, placebo-controlled trial

    Want to learn more?

    Check out:

    Take care!

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  • Resistance Beyond Weights

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    Resistance, Your Way

    We’ve talked before about the importance of resistance training:

    Resistance Is Useful! (Especially As We Get Older)

    And we’ve even talked about how to make resistance training more effective:

    HIIT, But Make It HIRT

    (High Intensity Interval Training, but make it High Intensity Resistance Training)

    Which resistance training exercises are best?

    There are two reasonable correct answers here:

    1. The resistance training exercises that you will actually do (because it’s no good knowing the best exercise ever if you’re not going to do it because it is in some way offputting to you)
    2. The resistance training exercises that will prevent you from getting a broken bone in the event of some accident or incident

    This latter is interesting, because when people think resistance training, the usually immediate go-to exercises are often things like the bench press, or the chest machine in the gym.

    But ask yourself: how often do we hear about some friend or relative who in their old age has broken their humerus?

    It can happen, for sure, but it’s not as often as breaking a hip, a tarsal (ankle bones), or a carpal (wrist bones).

    So, how can we train to make those bones strong?

    Strong bones grow under strong muscles

    When archaeologists dig up a skeleton from a thousand years ago, one of the occupations that’s easy to recognize is an archer. Why?

    An archer has an unusual frequent exercise: pushing with their left arm while pulling with their right arm. This will strengthen different muscles on each side, and thus, increase bone density in different places on each arm. The left first metacarpal and right first and second metacarpals and phalanges are also a giveaway.

    This is because: one cannot grow strong muscles on weak bones (or else the muscles would just break the bones), so training muscles will force the body to strengthen the relevant bones.

    So: if you want strong bones, train the muscles attached to those bones

    This answers the question of “how am I supposed to exercise my hips” etc.

    Weights, bodyweight, resistance bands

    If you go to the gym, there’s a machine for everything, and a member of gym staff will be able to advise which of their machines will strengthen which muscles.

    If you train with free weights at home:

    • Wrist curls (forearm supported and stationary, lifting a dumbbell in your hand, palm-upwards) will strengthen the wrist
    • The farmer’s walk (carrying a heavy weight in each hand) will also strengthen your wrist
      • A modified version of this involves holding the weight with just your fingertips, and then raising and lowering it by curling and uncurling your fingers)
    • Lateral leg raises (you will need ankle-weights for this) will strengthen your ankles and your hips, as will hip abductions (as in today’s featured video), especially with a weight attached.
    • Ankle raises (going up on your tip-toes and down again, repeat) while holding weights in your hands will strengthen your ankles

    If you don’t like weights:

    • Press-ups will strengthen your wrists
      • Fingertip press-ups are even better: to do these, do your press-ups as normal, except that the only parts of your hands in contact with the ground are your fingertips
      • This same exercise can be done the other way around, by doing pull-ups
      • And that same “even better” works by doing pull-ups, but holding the bar only with one’s fingertips, and curling one’s fingers to raise oneself up
    • Lateral leg raises and hip abductions can be done with a resistance band instead of with weights. The great thing about these is that whereas weights are a fixed weight, resistance bands will always provide the right amount of resistance (because if it’s too easy, you just raise your leg further until it becomes difficult again, since the resistance offered is proportional to how much tension the band is under).

    Remember, resistance training is still resistance training even if “all” you’re resisting is gravity!

    If it fells like work, then it’s working

    As for the rest of preparing to get older?

    Check out:

    Training Mobility Ready For Later Life

    Take care!

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  • Zucchini vs Okra – Which is Healthier?

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    Our Verdict

    When comparing zucchini to okra, we picked the okra.

    Why?

    Looking at the macros first, okra has nearly 2x the protein and more than 3x the fiber (for about 2x the carbs).

    In terms of vitamins, things are also quite one-sided; zucchini has a little more vitamin B2, while okra has a lot more of vitamins A, B1, B3, B5, B6, B9, C, E, K, and choline.

    Nor does the mineral situation make any compelling counterargument; zucchini is higher only in sodium, while okra has a lot more calcium, copper, iron, magnesium, manganese, phosphorus, potassium*, selenium, and zinc.

    *Actually it’s only a little more potassium. But the rest are with big margins of difference.

    Both of these on-the-cusp-of-being-pungent vegetables have beneficial antioxidant polyphenols (especially various forms of quercetin), but okra has more.

    In short: enjoy both, of course, but there’s a clear winner here and it’s okra.

    Want to learn more?

    You might like to read:

    Enjoy Bitter/Astringent/Pungent Foods For Your Heart & Brain

    Take care!

    Share This Post

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  • 10 Mistakes To Sabotage Your Ozempic Progress

    10almonds is reader-supported. We may, at no cost to you, receive a portion of sales if you purchase a product through a link in this article.

    Ozempic has a good reputation for getting reliable results, but there are ways to mess it up:

    It’s not just inject-and-go

    We’ll not keep the 10 ways a secret; they are:

    1. Increasing the dose too quickly: avoid cranking doses up too high too quickly, to prevent severe nausea, appetite suppression, and muscle loss. It’s worth being aware that high doses without proper management can lead to metabolic health disasters.
    2. Pushing through side effects: severe nausea or vomiting means you probably have an unhelpfully high dose; consult your prescribing doctor—it’s easy to feel “more is better; I don’t want to have less!”, but there really is a sweet spot, and if you’re not in it, then adjustments are needed in order to find it.
    3. Eating nutritionally scant food: reducing the quantity of unhealthy food isn’t enough—please prioritize nutrient-rich foods instead. Remember, “it’s not the calories in your food; it’s the food in your calories”.
    4. Consuming fried food and refined carbs: their general metabolic woes aside, fried foods and ultra-refined carbs can exacerbate nausea and other side effects, so it really is best to skip them. The good news is that Ozempic will help overcome those cravings more easily.
    5. Neglecting muscle protection: especially women, especially middle-aged or older, are at higher risk of osteoporosis and should maintain muscle mass (strong muscles and strong bones go together, by necessity). So, eat protein and do resistance training!
    6. Assuming it’s a monotherapy: GLP-1 drugs work best as part of a holistic protocol, including proper nutrition, strength training, and hormone therapy if appropriate.
    7. Not addressing metabolic health first: GLP-1 drugs are less effective in people with poor baseline metabolic health, so there’s a bit of a catch-22 here, but it’s important to be aware of. Fortunately, Ozempic and adopting a healthy lifestyle will each make the other work better.
    8. Neglecting comprehensive treatment plans: in other words, going through the motions of a holistic protocol and then expecting Ozempic to do all the work.
    9. Upping doses to overcome plateaus: plateaus often signal other issues (e.g. lack of protein, no strength training), so do address these before increasing dosage.
    10. Lack of collaboration with doctors: the human body is complex, and what’s going on metabolically is complex too, so there’s a lot a layperson can easily miss. For that matter, there’s a lot that doctors can easily miss too, but more heads are better than one.

    For more on all of these, enjoy:

    Click Here If The Embedded Video Doesn’t Load Automatically!

    Want to learn more?

    You might also like:

    5 Ways To Naturally Boost The Ozempic Effect

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  • The “Love Drug”

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    Get PEA-Brained!

    Today we’ll be looking at phenylethylamine, or PEA, to its friends.

    Not to be mistaken for the related amino acid phenylalanine! Both ultimately have effects on the dopaminergic system, but the process and benefits are mostly quite different.

    We thought we’d do this one in the week of Valentine’s Day, because of its popular association with love:

    ❝Phenylethylamine (PEA), an amphetamine-like substance that has been alluringly labeled the “chemical of love,” makes the best case for the love-chocolate connection since it has been shown that people in love may actually have higher levels of PEA in their brain, as surmised from the fact that their urine is richer in a metabolite of this compound. In other words, people thrashing around in the throes of love pee differently from others.❞

    Source: Office for Science and Society | The Chemical of Love

    What is it?

    It’s an amino acid. Because we are mammals, we can synthesize it inside our bodies, so it’s not considered an “essential amino acid”, i.e. one that we need to get from our diet. It is found in some foods, though, including:

    • Other animals, especially other mammals
    • Various beans, legumes, nuts, seeds. In particular almonds, soybeans, lentils, and chickpeas score highly
    • Fermented foods
    • Chocolate (popular lore holds this to be a good source of PEA; science finds it to be a fair option, but not in the same ballpark as the other items)

    Fun fact: the reason Marvel’s Venom has a penchant for eating humans and chocolate is (according to the comics) because phenylethylamine is an essential amino acid for it.

    What does it do for us?

    It’s a Central Nervous System (CNS) stimulant, and also helps us synthesize critical neurotransmitters such as dopamine, norepinephrine (adrenaline) and serotonin:

    β-Phenylethylamine Alters Monoamine Transporter Function via Trace Amine-Associated Receptor 1: Implication for Modulatory Roles of Trace Amines in Brain

    It works similarly, but not identically, to amphetamines:

    Amphetamine potentiates the effects of β-phenylethylamine through activation of an amine-gated chloride channel

    Is it safe?

    We normally do this after the benefits, but “it works similarly to amphetamines” may raise an eyebrow or two, so let’s do it here:

    • It is recommended to take no more than 500mg/day, with 100mg–500mg being typical doses
    • It is not recommended to take it at all if you have, or have a predisposition to, any kind of psychotic disorder (especially schizophrenia, or bipolar disorder wherein you sometimes experience mania)
      • This isn’t a risk for most people, but if you fall into the above category, the elevated dopamine levels could nudge you into a psychotic/manic episode that you probably don’t want.

    See for example: Does phenylethylamine cause schizophrenia?

    There are other contraindications too, so speak with your doctor/pharmacist before trying it.

    On the other hand, if you are considering ADHD medication, then phenylethylamine could be a safer thing to try first, to see if it helps, before going to the heavy guns of actual amphetamines (as are commonly prescribed for ADHD). Same goes for depression and antidepressants.

    What can I expect from PEA?

    More dopamine, norepinephrine, and serotonin. Mostly the former two. Which means, you can expect stimulation.

    For focus and attention, it’s so effective that it has been suggested (as we mentioned above) as a safer alternative to ADHD meds:

    β-phenylethylamine, a small molecule with a large impact

    …and may give similar benefits to people without ADHD, namely improved focus, attention, and mental stamina:

    Integrative Psychiatry | The Many Health Benefits of Phenylethylamine (PEA) – The Brain’s Natural Stimulant

    It also improves mood:

    ❝Phenylethylamine (PEA), an endogenous neuroamine, increases attention and activity in animals and has been shown to relieve depression in 60% of depressed patients. It has been proposed that PEA deficit may be the cause of a common form of depressive illness.

    Effective dosage did not change with time. There were no apparent side effects. PEA produces sustained relief of depression in a significant number of patients, including some unresponsive to the standard treatments. PEA improves mood as rapidly as amphetamine but does not produce tolerance.

    ~ Dr. Sabelli et al.

    Source: Sustained antidepressant effect of PEA replacement

    Where can I get it?

    We don’t sell it, but here is an example product on Amazon for your convenience 😎

    Enjoy!

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    Learn to Age Gracefully

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  • From Dr. Oz to Heart Valves: A Tiny Device Charted a Contentious Path Through the FDA

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    In 2013, the FDA approved an implantable device to treat leaky heart valves. Among its inventors was Mehmet Oz, the former television personality and former U.S. Senate candidate widely known as “Dr. Oz.”

    In online videos, Oz has called the process that brought the MitraClip device to market an example of American medicine firing “on all cylinders,” and he has compared it to “landing a man on the moon.”

    MitraClip was designed to spare patients from open-heart surgery by snaking hardware into the heart through a major vein. Its manufacturer, Abbott, said it offered new hope for people severely ill with a condition called mitral regurgitation and too frail to undergo surgery.

    “It changed the face of cardiac medicine,” Oz said in a video.

    But since MitraClip won FDA approval, versions of the device have been the subject of thousands of reports to the agency about malfunctions or patient injuries, as well as more than 1,100 reports of patient deaths, FDA records show. Products in the MitraClip line have been the subject of three recalls. A former employee has alleged in a federal lawsuit that Abbott promoted the device through illegal inducements to doctors and hospitals. The case is pending, and Abbott has denied illegally marketing the device.

    The MitraClip story is, in many ways, a cautionary tale about the science, business, and regulation of medical devices.

    Manufacturer-sponsored research on the device has long been questioned. In 2013, an outside adviser to the FDA compared some of the data marshaled in support of its approval to “poop.”

    The FDA expanded its approval of MitraClip to a wider set of patients in 2019, based on a clinical trial in which Abbott was deeply involved and despite conflicting findings from another study.

    In the three recalls, the first of which warned of potentially deadly consequences, neither the manufacturer nor the FDA withdrew inventory from the market. The company told doctors it was OK for them to continue using the recalled products.

    In response to questions for this article, both Abbott and the FDA described MitraClip as safe and effective.

    “With MitraClip, we’re addressing the needs of people with MR who often have no other options,” Abbott spokesperson Brent Tippen said. “Patients suffering from mitral regurgitation have severely limited quality of life. MitraClip can significantly improve survival, freedom for hospitalization and quality of life via a minimally invasive, now common procedure.”

    An FDA spokesperson, Audra Harrison, said patient safety “is the FDA’s highest priority and at the forefront of our work in medical device regulation.”

    She said reports to the FDA about malfunctions, injuries, and deaths that the device may have caused or contributed to are “consistent” with study results the FDA reviewed for its 2013 and 2019 approvals.

    In other words: They were expected.

    Inspiration in Italy

    When a person has mitral regurgitation, blood flows backward through the mitral valve. Severe cases can lead to heart failure.

    With MitraClip, flaps of the valve — known as “leaflets” — are clipped together at one or more points to achieve a tighter seal when they close. The clips are deployed via a catheter threaded through a major vein, typically from an incision in the groin. The procedure offers an alternative to connecting the patient to a heart-lung machine and repairing or replacing the mitral valve in open-heart surgery.

    Oz has said in online videos that he got the idea after hearing a doctor describe a surgical technique for the mitral valve at a conference in Italy. “And on the way home that night, on a plane heading back to Columbia University, where I was on the faculty, I wrote the patent,” he told KFF Health News.

    A patent obtained by Columbia in 2001, one of several associated with MitraClip, lists Oz first among the inventors.

    But a Silicon Valley-based startup, Evalve, would develop the device. Evalve was later acquired by Abbott for about $400 million.

    “I think the engineers and people at Evalve always cringe a little bit when they see Mehmet taking a lot of, you know, basically claiming responsibility for what was a really extraordinary team effort, and he was a small to almost no player in that team,” one of the company’s founders, cardiologist Fred St. Goar, told KFF Health News.

    Oz did not respond to a request for comment on that statement.

    As of 2019, the MitraClip device cost $30,000 per procedure, according to an article in a medical journal. According to the Abbott website, more than 200,000 people around the world have been treated with MitraClip.

    Oz filed a financial disclosure during his unsuccessful run for the U.S. Senate in 2022 that showed him receiving hundreds of thousands of dollars in annual MitraClip royalties.

    Abbott recently received FDA approval for TriClip, a variation of the MitraClip system for the heart’s tricuspid valve.

    Endorsed ‘With Trepidation’

    Before the FDA said yes to MitraClip in 2013, agency staffers pushed back.

    Abbott had originally wanted the device approved for “patients with significant mitral regurgitation,” a relatively broad term. After the FDA objected, the company narrowed its proposal to patients at too-high risk for open-heart surgery.

    Even then, in an analysis, the FDA identified “fundamental” flaws in Abbott’s data.

    One example: The data compared MitraClip patients with patients who underwent open-heart surgery for valve repair — but the comparison might have been biased by differences in the expertise of doctors treating the two groups, the FDA analysis said. While MitraClip was implanted by a highly select, experienced group of interventional cardiologists, many of the doctors doing the open-heart surgeries had performed only a “very low volume” of such operations.

    FDA “approval is not appropriate at this time as major questions of safety and effectiveness, as well as the overall benefit-risk profile for this device, remain unanswered,” the FDA said in a review prepared for a March 2013 meeting of a committee of outside advisers to the agency.

    Some committee members expressed misgivings. “If your right shoe goes into horse poop and your left shoe goes into dog poop, it’s still poop,” cardiothoracic surgeon Craig Selzman said, according to a transcript.

    The committee voted 5-4 against MitraClip on the question of whether it proved effective. But members voted 8-0 that they considered the device safe and 5-3 that the benefits of the device outweighed its risks.

    Selzman voted yes on the last question “with trepidation,” he said at the time.

    In October 2013, the FDA approved the MitraClip Clip Delivery System for a narrower group of patients: those with a particular type of mitral regurgitation who were considered a surgery risk.

    “The reality is, there is no perfect procedure,” said Jason Rogers, an interventional cardiologist and University of California-Davis professor who is an Abbott consultant. The company referred KFF Health News to Rogers as an authority on MitraClip. He called MitraClip “extremely safe” and said some patients treated with it are “on death’s door to begin with.”

    “At least you’re trying to do something for them,” he said.

    Conflicting Studies

    In 2019, the FDA expanded its approval of MitraClip to a wider set of patients.

    The agency based that decision on a clinical trial in the United States and Canada that Abbott not only sponsored but also helped design and manage. It participated in site selection and data analysis, according to a September 2018 New England Journal of Medicine paper reporting the trial results. Some of the authors received consulting fees from Abbott, the paper disclosed.

    A separate study in France reached a different conclusion. It found that, for some patients who fit the expanded profile, the device did not significantly reduce deaths or hospitalizations for heart failure over a year.

    The French study, which appeared in the New England Journal of Medicine in August 2018, was funded by the government of France and Abbott. As with the North American study, some of the researchers disclosed they had received money from Abbott. However, the write-up in the journal said Abbott played no role in the design of the French trial, the selection of sites, or in data analysis.

    Gregg Stone, one of the leaders of the North American study, said there were differences between patients enrolled in the two studies and how they were medicated. In addition, outcomes were better in the North American study in part because doctors in the U.S. and Canada had more MitraClip experience than their counterparts in France, Stone said.

    Stone, a clinical trial specialist with a background in interventional cardiology, acknowledged skepticism toward studies sponsored by manufacturers.

    “There are some people who say, ‘Oh, well, you know, these results may have been manipulated,’” he said. “But I can guarantee you that’s not the truth.”

    ‘Nationwide Scheme’

    A former Abbott employee alleges in a lawsuit that after MitraClip won approval, the company promoted the device to doctors and hospitals using inducements such as free marketing support, the chance to participate in Abbott clinical trials, and payments for participating in “sham speaker programs.”

    The former employee alleges that she was instructed to tell referring physicians that if they observed mitral regurgitation in their patients to “just send it” for a MitraClip procedure because “everything can be clipped.” She also alleges that, using a script, she was told to promote the device to hospital administrators based on financial advantages such as “growth opportunities through profitable procedures, ancillary tests, and referral streams.”

    The inducements were part of a “nationwide scheme” of illegal kickbacks that defrauded government health insurance programs including Medicare and Medicaid, the lawsuit claims.

    The company denied doing anything illegal and said in a court filing that “to help its groundbreaking therapy reach patients, Abbott needed to educate cardiologists and other healthcare providers.”

    Those efforts are “not only routine, they are laudable — as physicians cannot use, or refer a patient to another doctor who can use, a device that they do not understand or in some cases even know about,” the company said in the filing.

    Under federal law, the person who filed the suit can receive a share of any money the government recoups from Abbott. The suit was filed by a company associated with a former employee in Abbott’s Structural Heart Division, Lisa Knott. An attorney for the company declined to comment and said Knott had no comment.

    Reports to the FDA

    As doctors started using MitraClip, the FDA began receiving reports about malfunctions and cases in which the product might have caused or contributed to a death or an injury.

    According to some reports, clips detached from valve flaps. Flaps became damaged. Procedures were aborted. Mitral leakage worsened. Doctors struggled to control the device. Clips became “entangled in chordae” — cord-like structures also known as heartstrings that connect the valve flaps to the heart muscle. Patients treated with MitraClip underwent corrective operations.

    As of March 2024, the FDA had received more than 17,000 reports documenting more than 22,000 “events” involving mitral valve repair devices, FDA data shows. All but about 200 of those reports mention one iteration of MitraClip or another, a KFF Health News review of FDA data found.

    Almost all the reports came from Abbott. The FDA requires manufacturers to submit reports when they learn of mishaps potentially related to their devices.

    The reports are not proof that devices caused problems, and the same event might be reported multiple times. Other events may go unreported.

    Despite the reports’ limitations, the FDA provides an analysis of them for the public on its website.

    MitraClip’s risks weren’t a surprise.

    Like the rapid-fire fine print in television ads for prescription drugs, the original product label for the device listed more than 60 types of potential complications.

    Indeed, during clinical research on the device, about 6% of patients implanted with MitraClip died within 30 days, according to the label. Almost 1 in 4 — 23.6% – were dead within a year.

    The FDA spokesperson, Harrison, pointed to a study originally published in 2021 in The Annals of Thoracic Surgery, based on a central registry of mitral valve procedures, that found lower rates of death after MitraClip went on the market.

    “These data confirmed that the MitraClip device remains safe and effective in the real-world setting,” Harrison said.

    But the study’s authors, several of whom disclosed financial or other connections to Abbott, said data was missing for more than a quarter of patients one year after the procedure.

    A major measure of success would be the proportion of MitraClip patients who are alive “with an acceptable quality of life” a year after undergoing the procedure, the study said. Because such information was available for fewer than half of the living patients, “we have omitted those outcomes from this report,” the authors wrote.

    If you’ve had an experience with MitraClip or another medical device and would like to tell KFF Health News about it, click here to share your story with us.

    KFF Health News audience engagement producer Tarena Lofton contributed to this report.

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